Peripheral artery disease (PAD) includes stenosis and occlusion of upper- or lower-extremity arteries due to atherosclerotic or thromboembolic disease. PAD represents a spectrum of disease severity, encompassing both asymptomatic and symptomatic disease. In PAD, as blood vessels narrow, arterial flow into the extremities worsens, and symptoms may manifest either as classic intermittent claudication (IC) or as atypical claudication or leg discomfort. As the disease progresses, patients may develop more severe claudication, with reduced walking distance and eventually with rest pain. In 5 to 10 percent of cases, claudication progresses to a worsened severity of the disease, called critical limb ischemia (CLI)—defined as ischemic rest pain for more than 14 days, ulceration, or tissue loss/gangrene. Patients with CLI have a mortality of 25 percent at one year.
Multiple types of interventions are used for revascularization in patients with PAD, including open surgery, angioplasty (e.g., cryoplasty or angioplasty with drug-coated, cutting, or standard angioplasty balloons), stenting (e.g., with self-expanding or balloon-expandable stents are available), and atherectomy (e.g., using laser, directional, orbital, or rotational atherectomy devices). With improvements in endovascular techniques and equipment, the use of balloon angioplasty, stenting, and atherectomy has led to application of endovascular revascularization to a wider range of patients, both among those with more severe symptoms and those with less severe symptoms. However, such interventions frequently involve first traversing a stenosis with a wire, catheter, or treatment device, which poses a risk of embolizing debris even prior to the intervention